Tag Archives: #MedicalWriting

Training&Development

‘Medical writing’ is a perfect amalgamation of science and art. As a medical writer, one has to maintain a good balance between the technicality of science and art of communicating with the readers via words. Other than the basic requisite of knowledge of therapeutic areas, and command over the language; medical writing requires an understanding of the medical concepts and terminology, knowledge of relevant guidelines as regards the structure and contents of specific documents, and good writing skills.

The good news is that adeptness of effective medical writing can be easily learned by regular training and development!

Though there is no formal degree / diploma or certification course in medical writing, but there are few resources which can be utilized for gaining expertise in this discipline. These resources include; in-house medical training courses for employees provided by the various organization, short courses / workshops by professional bodies, on-the-job ‘mentor-guided’ training, and motivated “self-study”. Among all these resources, the motivated self –study is the mainstay and pertinent way of learning medical writing. Curiosity to learn and self-motivation can transform any mediocre into a seasoned medical writer. If one has a desire to take medical writing as a full-time career option then these five hacks can surely add value to the work;

#1 Read carefully, read regularly

New knowledge and information are constantly being added to the field of medicine. Every year a large number of papers are published related to various research studies, clinical experience, and new ideas and thoughts related to the healthcare industry. The best way to learn is to read through as many papers as possible. This teaches how to present data and what mistakes to avoid.

All the documents prepared under medical writing strictly abide by one or more technical guidelines issued by the regulating bodies. Therefore, a medical writer should be well-acquainted with the latest technical guidelines followed in different parts of the world. For instance, EU, USA, and Japan have evolved a set of common guidelines (International Conference on Harmonisation [ICH] guidelines) related to drug development and registration. For publication, Good Publication Practices, guidelines for reporting clinical trials (e.g. CONSORT), the International Committee of Medical Journal Editors’ (ICMJE) guidelines for manuscripts are mostly used. A medical writer should keep him/her updated with the latest versions of these guidelines.

Therefore reading carefully and reading regularly is a most important part of medical writing.

#2 Understand your audience well

The documents prepared by the medical writer have a different set of target audience, which may include; healthcare professionals, regulatory bodies, patients, and consumers. A medical writer should always try and take a reader’s perspective to understand how to approach a subject. The information in any document should be targeted in terms of the subject and the audience.
Therefore, it is very important that a medical writer identifies the target audience before writing.

#3 Pre-writing is a must

Pre-writing or drafting is an important part of medical writing. Before writing the first draft, develop a road map. Gain knowledge of the therapeutic area that is to be addressed, this enhance the relevance of articles being searched. Reading about the therapeutic area is very important prior starting the literature search. The literature search should be followed by, arranging key facts and citations from the literature into a crude roadmap/outline. Follow the outline meticulously, for writing a well-organized document.

#4 Write Lucid, clear and crisp

While writing, be clear and specific, and strictly avoid beating around the bush. The main idea/ objective of the document should be clear from first few paragraph of the document. Remember, while reading, a reader follows an “F” pattern i.e. the first few paragraphs are read carefully and the remaining document is scanned in an F pattern. Hence, it is very important to keep all the key information in the first few paragraphs, to keep a reader hooked to the article.Adding sub-heading also helps to catch readers attention.

The information should be well- organized. In the margins of your paper, tag each paragraph with a phrase or sentence that sums up the main point. Then move paragraphs around to improve logical flow and bring similar ideas together.

#5 Revise well before submitting

Before submitting your work, proofread and edit it well. Remember, a sentence written incorrectly will not convey any meaning or add value to your document. Read each sentence more than once to identify grammatical errors. While revising your work; read out loud, do a verb check, cut clutter, do an organizational review, and get feedback from others.

As quoted by William Zinsser- “If writing seems hard, it’s because it is hard. It’s one of the hardest things people do”. Though, practising regularly and keeping one well-versed with the latest happenings of the domain can ease down the task.

Turacoz Healthcare Solutions as a socially responsible company spreads the word and awareness and looks forward to collaboration or associations with other agencies/companies with similar goals and aspirations. We have a skilled and competent team of medical writers, clinicians, researchers and biostatisticians. Our clients include major pharmaceutical companies, hospitals and healthcare professionals. Our experience has been in supporting publications, creating regulatory documents, conducting observational studies, designing and creating for print and digital marketing as well as customizing sessions on medical writing. 

#Biostatistics

Clinical studies are conducted to test the drugs and medical devices in humans before their approval and availability for the commercial market. To understand the results of clinical studies, clinical research professionals need to use statistical analysis. Biostatistics helps them to understand the different aspects of the study which enable to interpret the results of the study in more scientific way. It involves the biostatistician immediately after conceptualization of the research question. This will make sure that you design the study accurately. Introduction of the biostatistician in the middle of the study can result in several pitfalls in the study design.

Now, question may arise why there is need for biostatistics in human research? The simple answer can be to understand the concept of variation and sampling. Attributes are not only different among the individuals but they could also be different within the same individual over the time. Human research mostly conducted on small sample size and it’s indeed a tedious task to express the results from small sample size. Therefore, biostatistics plays an important role in human medical research.

The most common medical writing tips for the use of biostatistics in human research are provided below:

  • How was data collected?

For a survey type of study, describe the method of data collection and provide pertinent details, such as the number of questions, range of questionnaire response scores and the meaning of each score.

  • Use simple models for defined parameters

In data analysis, particularly for complex high-dimensional data, it is frequently better to choose simple models for clearly defined parameters.

  • Which statistical software used?

Mention the statistical software and the version used in the analysis, and details such as the manufacturer of the software, city, and country of origin in parenthesis.

  • What all to describe?

Provide clear descriptions of the main features of the statistical analysis (e.g. confidence interval, including degree of confidence; hypothesis tests, including null and alternative hypotheses; level of significance; particular tests and test statistics).

  • Why is data review essential?

To determine the quality of the data, initially look at the bad data first and then remove the suspected data. This would save a lot of time and rework later.

  • How did you manage outliers?

Describe the procedures that were put in place to handle missing values and data, as well as any outliers (provide the definition used for an outlier).

  • What should be the sample size?

To minimize the sampling error effect, large sample size need to be collected. The confidence interval can then be computed and visualized in excel. This enables to make most of small and large sample sizes.

  • Why should you describe study design?

The study design should be described accurately and in detail so that the study can be reproduced, if required. Study/sampling/data flow charts can be used to describe complicated sampling/study designs.

  • What is the role of data management?

Data management is the foundation to well done studies. Statistical team’s participation during study design is important for well reported results.

  • Some more tips
    • A pleasant appearance, coupled with visual interest, can draw the reader through the text and reduce the effort of reading. Use of tables, figures, and graphs provide visual interest and can help clarify a complex message.
    • Use appropriate measures of central tendency and spread as summary statistics; for instance, report medians for highly skewed data. If using the notation a ± b, clearly state what b is – it could be standard deviation or standard error.
    • Use tables to report summary statistics, summaries of results, or the quantities associated with a p-value.

Biostatistics gives you the rationale behind extrapolating the results to larger population and these figures are very important in our day to day science. Learning the basics of biostatics’ is necessary for medical writers as this knowledge can help them to give the explanations of the results and what impact will they have on patient care and outcome.

Turacoz Healthcare Solutions as a socially responsible company spreads the word and awareness and looks forward to collaboration or associations with other agencies/companies with similar goals and aspirations. We have a skilled and competent team of medical writers, clinicians, researchers and biostatisticians. Our clients include major pharmaceutical companies, hospitals and healthcare professionals. Our experience has been in supporting publications, creating regulatory documents, conducting observational studies, designing and creating for print and digital marketing as well as customizing sessions on medical writing. 

#PublicationEthics

Publishing the results of a study completes the research conducted. As mentioned by EH Miller, “If it was not published, it was not done”. Although there are numerous guidelines and checklists that one follows under the publication cycle, following publication ethics is of top priority. Every aspect of publishing a manuscript is guided by ethical principles. Most peer reviewed journals, keep publication ethics their top most requirement failing which the manuscript cannot be accepted. The World Association of Medical Editors (WAME) strives to reinforce and make recommendations on publication ethics to the scientific community.

Any study begins with a study design. The study design must be made to adequately address the research question. Approval of the study design with every aspect must be obtained prior to the beginning of the study from the institutional review board or ethics committee. In addition, all animal studies must be conducted with full compliance of the local, national, ethical, and regulatory principles, and the local licensing arrangements.

Ensuring that the work being published is original, all authors enlisted are aware of the submission, obtaining copyright permission for tables and figures, including paper affiliations, and ensuring that the manuscript has not been submitted to more than one journal at a time are a mandate for following publication ethics. Other important types of ethical violations include failure to inform the editor regarding related papers, unrevealing the conflict of interests which may affect the results of the study, misinterpretation of research findings by the use of selective or fraudulent data to support a hypothesis or claim.

Breach of publication ethics sooner or later come to light leading to unavoidable consequences. In most cases, the manuscript is retracted or the authors may be asked to submit an apology to the corresponding journal of submission. In severe cases, the authors of the paper may be blacklisted from further submissions in the journal which can hamper the reputation of the authors in the scientific committee.

In conclusion, any kind of breach can be avoided by preparing a focused manuscript with originality. Appropriate citing of references to avoid plagiarism and declaration of conflict of interests among the authors must be considered. Adequate knowledge of the ethical guidelines is the key factor for preparation of documents which comply with all ethical principles.

Turacoz Healthcare Solutions as a socially responsible company spreads the word and awareness and looks forward to collaboration or associations with other agencies/companies with similar goals and aspirations. We have a skilled and competent team of medical writers, clinicians, researchers and biostatisticians. Our clients include major pharmaceutical companies, hospitals and healthcare professionals. Our experience has been in supporting publications, creating regulatory documents, conducting observational studies, designing and creating for print and digital marketing as well as customizing sessions on medical writing.